Status:
COMPLETED
Study of a Booster Dose of IMOJEV® One Year After Primary Immunization in Healthy Children in South Korea
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Japanese Encephalitis
Eligibility:
All Genders
2-4 years
Phase:
PHASE3
Brief Summary
The aim of this study was to document the immunogenicity and safety of a booster dose of IMOJEV administered at least 12 months after the primary dose. Primary objective: * To describe the immune re...
Detailed Description
Participants who previously participated in Study JEC12 (NCT01396512) and were primed with IMOJEV received a booster dose of IMOJEV at least 12 months after the primary dose. Participants were assesse...
Eligibility Criteria
Inclusion
- Must have participated in study JEC12 and received 1 dose of IMOJEV at least 12 months before booster vaccination
- Age 2 to 4 years on the day of inclusion
- In good general health at the time of inclusion
- Informed Concent Form signed and dated by parent(s) or another legally acceptable representative(s)
- Subject and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and comply with all study procedures.
Exclusion
- Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the study vaccination
- Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Receipt of immune globulins, blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response
- Previous vaccination against flavivirus disease, including JE, with another vaccine, except with IMOJEV® while participating in JEC12
- Administration of any anti-viral within 2 months preceding Visit 1 and up to the 4 weeks following the study vaccination
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination, except for inactivated influenza vaccination, which may be received at least 2 weeks before the study vaccine
- History of central nervous system disorder or disease, including seizures
- Planned receipt of any JE vaccine during the course of the study
- History of flavivirus infection (confirmed either clinically, serologically or virologically)
- Administration of systemic corticosteroids for more than 2 consecutive weeks within the 4 weeks preceding vaccination
- Thrombocytopenia, contraindicating vaccination
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating vaccination
- Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection 3 days before vaccination as well as the day of vaccination, according to Investigator judgment. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
- In an emergency setting or hospitalized involuntarily
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
Key Trial Info
Start Date :
July 11 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2014
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT01900444
Start Date
July 11 2013
End Date
March 11 2014
Last Update
March 28 2022
Active Locations (8)
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1
Investigational Site 004
Gyeonggi-do, South Korea
2
Investigational Site 010
Gyeonggi-do, South Korea
3
Investigational Site 001
Seoul, South Korea
4
Investigational Site 005
Seoul, South Korea